Abstract
With the increase in mammalian cell-expressed recombinant biotherapeutics, the process of accelerating the selection of generated stable mammalian cell lines is becoming a critical step in cell line development pipelines. The selection process is known to be a major bottleneck in obtaining a cell line from development into manufacturing, but with the current sales of biotherapeutics reaching close to US$125 billion with monoclonal antibodies being more than 50 % of the sales, there is no sign of a decrease in demand and the amount of cell line development projects in the pipeline will keep increasing. This means that more efficient cost effective cell line selection strategies are critical to meet demand for affordable biologics. The current advancements in the cell line selection process has helped in this regard, by reducing some of the labor and time required to reduce heterogeneity and determine clonality of a cell line expressing a quality biotherapeutic protein at the highest specific productivity possible. However, challenges remain in dealing with the sheer volume of cells that need to go through the screening process for the determination of a stable highly productive clone. This chapter will provide a summary of the methodology and strategies employed to select the desired cell lines that meet the demands of the biopharmaceutical manufacturing environment from manual selection to automated systems that aid in the mammalian cell line selection process.
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Kuystermans, D., Al-Rubeai, M. (2015). Mammalian Cell Line Selection Strategies for High-Producers. In: Al-Rubeai, M. (eds) Animal Cell Culture. Cell Engineering, vol 9. Springer, Cham. https://doi.org/10.1007/978-3-319-10320-4_11
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